Cefazolin Sala 2 g powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefazolina Sala 2 g powder for injectable solution EFG

Cefazolin

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Cefazolina Sala is and what it is used for.
2. What you need to know before using Cefazolina Sala.
3. How to use Cefazolina Sala.
4. Possible side effects.
5. How to store Cefazolina Sala.
6. Contents of the pack and other information.

1. What Cefazolin Sandoz is and what it is used for

Cefazolin is an antibiotic belonging to the cephalosporin group.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is used to treat the following bacterial infections caused by susceptible pathogens affecting:

• respiratory tract
• urinary tract
• skin and soft tissues
• joints
• heart
• blood (septicaemia)
• for the prevention of infections in surgery.

2. What you need to know before starting to take Cefazolin Sala.

Do not use Cefazolin Sala

• If you are allergic (hypersensitive) to cefazolin, to other cephalosporins, or to any of its components.

Warnings and precautions

Take special care with Cefazolin Sala

• If you develop severe and persistent diarrhea, this may be due to a particular type of colitis called pseudomembranous colitis, which can be serious. In such cases, your doctor will decide whether cefazolin treatment should be discontinued and appropriate therapy initiated.

• If you are undergoing prolonged treatment with cefazolin, superinfections may occur.

• If you have renal impairment, your doctor may need to adjust the dose of cefazolin you should receive.

• If you need to undergo any blood tests, you must inform healthcare personnel that you are being treated with this medicine, as cefazolin may interfere with test results.

• Signs of allergic reaction, including respiratory problems and chest pain, have been reported with the use of cefazolin. Immediately stop using cefazolin and contact your doctor immediately or go to emergency services if you experience any of these symptoms.

Risk factors that may cause vitamin K deficiency or risk factors affecting other mechanisms of blood coagulation.

Rarely, coagulation disorders may occur during treatment with cefazolin. Additionally, changes in blood coagulation may occur in patients with conditions that may cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In such cases, your blood coagulation will be monitored.

Other medicines and Cefazolin Sala

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Cefazolin should not be administered concomitantly with:

• Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol.
• Anticoagulants
• Probenecid (used to treat gout)
• Nephrotoxic agents

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, your doctor will decide whether it is appropriate to use this medicine. Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Cefazolin generally does not impair the ability to drive vehicles or operate machinery.

Cefazolin Sala contains sodium

Patients on low-sodium diets should be aware that this medicine contains 101 mg (4.4 mmol) of sodium per gram of cefazolin.

3. How to use Cefazolin Sala

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose and duration of your treatment; do not stop or extend it prematurely.

Recommended dose

Adults and children over 12 years of age: in mild infections, 500 mg every 8 hours; in moderate to severe infections, 500 mg to 1 g every 6 or 8 hours; in more severe infections, 1 g to 1,500 mg every 6 hours.

Children (under 12 years and over 1 year of age): a total daily dose of 25 to 50 mg per kg of body weight, divided into three or four equal doses, is effective in most mild to moderate infections. The total daily dose should not exceed 100 mg/kg, even in cases of severe infection.

Prophylactic treatment

• 1-2 g administered intravenously, given from 30 minutes to one hour before starting surgery.

• for prolonged surgical procedures (e.g., two hours or longer), 500 mg to 1 g intravenously during surgery (administration will be adjusted depending on the duration of the procedure).

• 500 mg to 1 g intravenously every six to eight hours for 24 hours postoperatively.

Patients with renal and/or hepatic impairment

A dose reduction may be necessary if you have renal or hepatic impairment. In such cases, inform your doctor so that your dose can be appropriately adjusted.

If you use more Cefazolin Sala than you should:

In case of accidental overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested. Bring the package leaflet with you.

If you forget to use Cefazolin Sala

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Cefazolin Sala

Do not discontinue treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended duration; otherwise, the infection could worsen.

If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause the following adverse effects, although not everyone will experience them.

The frequencies of adverse reactions associated with treatment with Cefazoina Sala are classified as follows:

Severe allergic reactions (very rare, may affect up to 1 in 10,000 people).

If you experience a severe allergic reaction, inform your doctor immediately.

Possible symptoms include:

• Sudden swelling of the face, throat, mouth or lips, which may cause difficulty in
  breathing or swallowing.

• Sudden swelling of hands, feet and ankles.

Other possible adverse effects

Common (may affect up to 1 in 10 people):

• Skin rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or induration (hardened skin) at the injection site.

Uncommon (may affect up to 1 in 100 people):

• Fungal mouth infection.
• Fever.
• Seizures (attacks).
• Inflammation of veins.
• Itching and redness of the skin, joint pain, skin lesions, generalized rash and
  urticaria.

Rare (may affect up to 1 in 1,000 people):

• Genital infection, vaginal candidiasis — vaginal pain and itching or vaginal discharge.

• Prolonged use may lead to overgrowth of non-susceptible bacteria.

• Increased or decreased number of blood cells.

• Hyperglycaemia (high blood sugar level), hypoglycaemia (low blood sugar level).

• Dizziness.

• Respiratory disorders (breathing).

• Disorders of the kidneys and urinary tract.

• Cough.

• Rhinorrhoea.

• Loss of appetite.

• Liver failure (detectable in blood tests), jaundice.

• Severe rapidly progressing skin rash (with blisters and skin peeling, and possible
  blisters in the mouth).

• Severe fatigue and weakness.

• Chest pain.

Very rare (may affect up to 1 in 10,000 people):

• Blood coagulation disorders.

• Inflammation of the colon. Symptoms include diarrhea, usually with blood and mucus, abdominal
  pain and fever.

• Genital itching.

Frequency not known (cannot be estimated from available data):

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefazolin Sala

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store in the outer packaging to protect from light.

The reconstituted solution is stable for 8 hours at a temperature not exceeding 25°C and for 24 hours if stored in the refrigerator (2–8°C).

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Cefazolina Sala

The active substance is cefazolin. Each vial contains 2 g of cefazolin (D.O.E.) (as sodium cefazolin).

Appearance of the product and contents of the pack

Cefazolina Sala 2 g powder for injectable solution EFG is supplied in a glass vial.

Each pack contains 1 vial and the clinical pack contains 50 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10 – 08970

Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofre, S.A.

C/Jarama 11, Polígono industrial - 45007

Toledo - Spain

This summary of product characteristics was last approved in: March 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Intravenous administration: cefazolin may be administered by direct intravenous injection or by continuous or intermittent infusion (never dissolved in lidocaine).

1. Continuous or intermittent intravenous infusion: cefazolin may be administered through standard intravenous fluid delivery systems, with control of the infusion rate, or via a secondary intravenous infusion bag. Reconstitute 500 mg or 1 g of cefazolin with its solvent (not with lidocaine) and then dilute in 50 to 100 ml of one of the following intravenous solutions:

0.9% Sodium chloride

5% or 10% Glucose

5% Glucose in Ringer's lactate

0.9% Sodium chloride and 5% Glucose

0.45% Sodium chloride and 5% Glucose

Ringer's lactate

5% or 10% Fructose in Water for Injection

2. Direct intravenous injection (bolus):

Reconstituted 500 mg or 1 g: diluted in 10 ml of Water for Injection.

Reconstituted 2 g: diluted in a minimum of 20 ml of Water for Injection.

The solution should be injected slowly over 3 to 5 minutes (must not be administered in less than three minutes).